Biologics Development Lead: Cell Culture & Commercialization

Merck & Co.; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays

Vacation and sick days

Job summary

Merck & Co. seeks a Biologics Cell Culture Commercialization Leader to guide technical direction across DS commercialization, process characterization, tech transfer, and regulatory filings.

You will lead a team of scientists, align cross-functional resources, and drive PPQs, BLAs, and global health authority licensing for late-stage pipeline products. Responsibilities include developing robust cell culture strategies, ensuring compliance, mentoring staff, and partnering with internal and

Qualifications

• Proven leadership of functional teams in biologics development & commercialization.
• Deep expertise in cell culture commercialization and manufacturing operations.
• Strong understanding of regulatory requirements.
• Ability to lead without authority, build trust, and inspire accountability.
• Ethical, resilient, and committed to excellence.
• Skilled in risk management, team facilitation, and strategic planning.
• Experience in commercial manufacturing and CMC development.
• Exceptional communication and stakeholder engagement skills.

Responsibilities

• Technical Strategy: Deliver robust DS strategies for successful commercialization. Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
• Technical leadership: Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.
• CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
• Leadership: Establish, manage and support Cell Culture CMC teams, and align resources to deliver on priorities. Manage and mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff.
• Cross-Functional Collaboration: Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity.
• Problem Solving: Remove roadblocks, resolve conflicts, and elevate issues when needed.
• Communication: Foster collaboration, ensure transparency, and engage with governance bodies. Excellent interpersonal and communication skills.
• Project Management: Drive project schedules, set clear priorities, and monitor performance metrics. Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.
• Recognition: Celebrate team achievements and foster a culture of appreciation.
• Innovation: Lead business improvement initiatives and leverage your network to drive change.

Skills

Biologics

Mammalian cell culture

Commercialization

Leadership

Regulatory compliance

CMC development

Process development

Risk management

Regulatory submissions

Cross-functional leadership

Education

Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering

Master's degree in Chemical Engineering, Bioengineering, Biological Engineering

Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering

Job description

Merck & Co. seeks a Biologics Cell Culture Commercialization Leader to guide technical direction across DS commercialization, process characterization, tech transfer, and regulatory filings.

You will lead a team of scientists, align cross-functional resources, and drive PPQs, BLAs, and global health authority licensing for late-stage pipeline products. Responsibilities include developing robust cell culture strategies, ensuring compliance, mentoring staff, and partnering with internal and